Health Condition 1: null- Patients on Myelosuppressive Therapy for Non Myeloid Malignancies
Conditions
Interventions
Intervention1: Cadila G-CSF: Cadila rh G-CSF in the dose of 300 micro gram once/ day for a maximum of 14 days (or till post nadir absolute neutrophil count reaches to â?¥10000/cubic mm) by sub cutaneu
Sponsors
Cadila Pharmaceuticals Ltd
CRO Cadila Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subject of either sex aged 18 years or more having any Histologically confirmed malignancy (except myeloid malignancies and myelodysplastic syndromes) undergoing a variety of myelosuppressive chemotherapy regimens 2. Patients should have performance status of 0-2 ECOG (European Cooperative Oncology group (Appendix 3) 3. Subjects with >= 20% risk of developing chemotherapy induced febrile neutropenia. Subjects receiving chemotherapy regimens with (Appendix 6), National Comprehensive Cancer Network (NCCN) guideline for myeloid growth factor v.1.2008) intermediate to high risk for febrile neutropenia are eligible. 4. Ability of patients to understand and the willingness to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subject with history or clinical evidence of serious benign medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the Investigator with or without specific investigations. 2. Patient has any condition which is considered as a contraindication for the use of GCSF or which, in the opinion of the Investigator may put the patient increased risk versus any supposed benefit of treatment with GCSF. 3. Subject with body weight 45 kg 4. Patients have any prior history of bone marrow / stem cell transplantation or may require in near future in the Investigatorâ??s opinion 5. Patients having active infection 6. Patients who have clinically significant uncontrolled medical illness except malignancy 7. Patients having renal impairment (serum creatinine >= 1.5 times the upper normal limit) and abnormal liver function total bilirubin >= 2 times the upper limit of normal, SGOT & SGPT >= 5 times the upper limit of normal) 8. Patients who have involvement of bone marrow 9. Patients receiving simultaneous radiotherapy 10. Current therapy with other investigational drugs or lithium. 11. History or clinical evidence of congestive heart failure (NYHA class III-IV). (Appendix 4) 12. Prior treatment with antibiotics, interferons, interleukins, or, colony stimulating factors (including G-CSF, GM- CSF, M-CSF and erythropoietin) within last 10 days of enrolment. 13. Pregnant women, nursing women and women not practicing effective contraception. 14. Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication. 15. Patients with clinical symptoms of acute Hepatitis B or C infection. 16. Patients unwilling to give informed consent or unable to follow study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients developing febrile neutropenia (defined as body temperature â?¥ 38.2°C or developing a temperature of 38°C twice in a 12-hour period and absolute neutrophil count 0.5 x 10e9/L on the same day of the fever or the day after.Timepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients developing adverse events and/ or changes in laboratory values. Incidence of neutropenia defined as absolute neutrophil count 0.5 x 10e9/L not associated with fever â?¢ Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Bhaumik Mody
CRO Cadila Pharmaceuticals Limited
Outcome results
None listed